Location: Houston, TX
Reports to: Head of Quality Regulatory
Job type: Full-Time
Salary: 80K annually

Qbtech is the global market leader in professional ADHD tests, providing tests that are both CE marked and FDA cleared for use as an aid in the assessment and treatment evaluation of ADHD for people age 6-60. Our vision is to transform healthcare by providing a complete system of leading objective tests, products and services that empowers clinical and financial decision-makers to improve outcomes and support patients to better understand their symptoms and treatment.

Qbtech is present in 14 countries with offices in Stockholm, London and Houston. Qbtech is making significant investments into new products, technologies and people to further strengthen our services and product offerings with the aim of building an ecosystem with solutions for providers, clinicians and patients. 

Job Summary:

We are looking for a Quality Assurance Regulatory Affairs Manager to join our global QA/RA department to to support Quality Management System (QMS), update and implementation at Qbtech´s subsidiary in the United State.

The QARA Manager will act as US-agent Coordinator for Qbtech, with all tasks and responsibilities this role concerns.

Duties/Responsibilities:

● Perform facility and product registration in FDA´s database.
● Coordinate/ act as contact person for interactions with regulatory authorities (notified bodies included) and face to face meetings in Northern America; submission, reportable adverse events etc.
● Coordinate/ act as the host when the organization is subject for product clearance inspection or QMS audit.
● Have a great knowhow in Qbtech QMS, ISO13485 and Medical Device legislations, in order to provide support and advice to the organization.
● Perform internal and supplier audits.
● Secure document and record control.
● Coordinate quality processes and records; CAPA, Change Control, compliance and non-conformance handling.
● Perform training in QMS.
● Act as the deputy to Project Quality Regulatory Manager and/or System Quality Regulatory Manager at Qbtech head office.

Competency Required for Position:

● Knowledge of current revision of ISO13485:2016 and US 21 CFR Part 820.
● Knowledge of Premarket Notification and Premarket Approval processes.
● Knowledge of Medical Device Development.

Competency Desired for Position:

● Knowledge of current revision of ISO27001.
● Knowledge of Regulation (EU) 2017/745.

Qualifications Required for Position:

● Adequate scientific education. BSc or higher.
● Experienced from previous work with Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
● Experienced from previous work with Medical Device Development.
● High ability to interact with internal and external stakeholders.
● US citizen or having the US green card.
● Able to pass a background check.

Work Environment
● Hybrid working, with office located in Houston, Texas.
● Some domestic and international travel is required.
● Clean driving records.

What can Qbtech offer you?
Qbtech was founded in 2002, today we are over 80 employees working from Sweden, Netherlands, UK and USA with customers in all parts of the world. We are on a growth path and looking to double the team in 18 months. If you are passionate about transforming health care and work on great technology products, then don’t hesitate to apply!